NCT05035615Completed
Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer
Evaluation of the BD OneFlow Acute Leukemia Panel (BD OneFlow ALOT, BCP-ALL T1, and AML T1-T4) on the BD FACSLyric Flow Cytometer Using Leftover, De-identified Specimens
Source: ClinicalTrials.gov · Last updated 6 Aug 2024
Brief summary (registry, in English)
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 332 (actual)
- First submitted
- 27 Aug 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 29 Jun 2024
- Lead sponsor
- Becton, Dickinson and Company
- Diseases
- Childhood cancers
- NCT number
- NCT05035615
What you commit to
- Study type: Observational
- Participants enrolled: 332
- From 2 Nov 2021 to the primary completion date, 29 Jun 2024
- 8 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Specimen is from subject with minimal residual disease (MRD) as determined by the site.
- Specimen is from subject suspected of plasma cell disorders.
Age
- Specimen from subject \<3 years of age.
Other
- Specimen is from healthy subject.
- Specimen is from subject undergoing any treatment for any form of leukemia.
- Visibly clotted specimen.
- Visibly hemolyzed specimen.
- Frozen specimen.
- Refrigerated specimen.
- Fixed specimen.
Who the study is looking for
- Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- Specimen with adequate volume (1 mL) to complete protocol tests.
- Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders.
- Specimen from newly diagnosed or relapsed subject.
- Only one specimen type (PB or BM) shall be enrolled per given subject.
- Specimen is stored at room temperature, upon receipt by the site.
- Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
- Age of specimen (BCP ALL T1: time of collection to start of first pre-wash; ALOT, AML T1-T4: time of collection to start of staining): ≤ 24 hours.
- Specimens are from subjects irrespective of race, gender, and ethnicity
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fleury Group Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Motol University Hospital, Childhood Leukemia Investigation Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University of Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Cambridge University Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Childrens Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| New York-Presbyterian Hospital Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| CorePath Laboratories Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.